A Safety, Tolerability, Pharmacokinetic and Efficacy Study of Azithromycin Plus Piperaquine as Presumptive Treatment in Pregnant PNG Women
NCT ID: NCT02575755
Last Updated: 2015-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2012-10-31
2016-10-31
Brief Summary
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The aim of the present trial is to assess the safety, tolerability, pharmacokinetics and efficacy of azithromycin (AZI) plus piperaquine (PQ) given as IPTp to pregnant Papua New Guinea women. The study will comprise of two sub-studies:
(i) A safety, tolerability and pharmacokinetic study of AZI-PQ in pregnancy. (ii) A safety, tolerability and preliminary efficacy study of AZI-PQ in pregnancy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Efficacy Study: Azithromycin plus piperaquine
At baseline, participants receive three daily doses (0, 24 and 48 hours) of i) 1 g azithromycin as 2 x film-coated 500 mg tablets ii) 960 mg piperaquine tetraphosphate tablets as 3 x 320 mg tablets
Azithromycin plus piperaquine phosphate
Efficacy Study Control: National Standard Treatment
At baseline, participants receive a single dose of sulfadoxine-pyrimethamine comprising 1,500 mg of sulfadoxine and 75 mg pyrimethamine in tablet form
Sulfadoxine-pyrimethamine
Pharmacokinetic Study: Azithromycin plus piperaquine
At baseline, participants receive three daily doses (0, 24 and 48 hours) of i) 1 g azithromycin as 2 x film-coated 500 mg tablets ii) 960 mg piperaquine tetraphosphate tablets as 3 x 320 mg tablets
Azithromycin plus piperaquine phosphate
Interventions
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Azithromycin plus piperaquine phosphate
Sulfadoxine-pyrimethamine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No signs of severe malaria by World Health Organisation criteria
* No significant concomitant disease (such as TB)
* No prior history of an adverse reaction to AZI or PQP
* No prior treatment with these drugs in the past 4 weeks
* Can attend all follow-up visits
* Provide informed consent
Exclusion Criteria
* Significant concomitant disease such as TB as assessed by the attending clinician
* A history/family history of sudden death or of congenital prolongation of the QTc interval
* Any clinical condition known to prolong the QTc interval
* A history of complicated pregnancies/deliveries
* A prior history of an adverse reaction to AZI or PQP
* Have taken these drugs in the past 4 weeks
* Cannot attend any of the follow-up visits
* Do not provide informed consent
18 Years
FEMALE
Yes
Sponsors
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The University of Western Australia
OTHER
University of Melbourne
OTHER
Malaria in Pregnancy Consortium
OTHER
Papua New Guinea Institute of Medical Research
OTHER_GOV
Responsible Party
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Locations
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Papua New Guinea Institute of Medical Research
Madang, Madang Province, Papua New Guinea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MRAC10.53
Identifier Type: -
Identifier Source: org_study_id
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